A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:
Ununited humeral head fractures;
Avascular necrosis of the humeral head.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
Ununited humeral head fractures;
Avascular necrosis of the humeral head.
The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing alignment; restoring flexion and extension movement: and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

Rotator cuff tear arthropathy.
Difficult clinical management problems where other methods of treatment may not be inadequate.
The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.

The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
Ununited humeral head fractures;
Avascular necrosis of the humeral head.
The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.

The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:

Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
For US use only: All components are intended for cemented use only

Device Description

The Global Shoulder System is comprised of multiple brands (Global Advantage, Global FX, Global AP, Global CAP, Global APG and Global Steptech), each comprised of different components (humeral stems, humeral heads and glenoids) intended for hemiand/or total-shoulder arthroplasty.
The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.

AI/ML Overview

This is a 510(k) premarket notification for various DePuy shoulder systems (Global Shoulder, Delta CTA, etc.). The document details the device names, indications for use, and a comparison to predicate devices, focusing on the addition of MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-clinical testing performed to support MRI compatibility. The reported device performance is that these tests demonstrated compatibility.

Acceptance Criterion (Implied)	Reported Device Performance
Magnetic Resonance (MR) compatibility of the shoulder systems.	Results demonstrated compatibility conditions of the subject devices in the MR environment.
Compliance with ASTM F2213 (Magnetically Induced Torque)	Demonstrated
Compliance with ASTM F2052 (Magnetically Induced Displacement Force)	Demonstrated
Compliance with ASTM F2119 (MR Image Artifacts)	Demonstrated
Compliance with ASTM F2182 (Radio Frequency Induced Heating)	Demonstrated

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for AI performance. Instead, it refers to non-clinical testing for MRI compatibility.

Sample size: Not applicable or not specified in terms of patient numbers. The testing was done on the devices themselves.
Data provenance: Not applicable. These are physical tests on the medical devices, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is about the physical device and its MRI compatibility, not an AI/ML device requiring expert-established ground truth from medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. This refers to the adjudication of clinical review for AI/ML performance, which is not relevant here. The tests performed are standardized engineering tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the MRI compatibility testing, the "ground truth" would be the specifications and limits defined by the ASTM standards themselves. The physical properties of the devices are measured against these established limits.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no training set mentioned or implied.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 2, 2021

DePuy Inc. Megan Bernier Regulatory Affairs Specialist 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K203230

Trade/Device Name: Global Shoulder and Delta CTA systems Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, MBF, PHX Dated: February 19, 2021 Received: February 22, 2021

Dear Megan Bernier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

{1}------------------------------------------------

including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K203230

Device Name

Trade Name: GLOBAL ADVANTAGE

Indications for Use (Describe) The DePuy GLOBAL ADVANTAGE Shoulder Systems

The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
1. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:

Ununited humeral head fractures;

1. Avascular necrosis of the humeral head.
  GLOBAL ADVANTAGE CTA Humeral Heads

The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.

The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.

GLOBAL ADVANTAGE Shoulder Systems Fixation Methods

The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:

POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for

cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.

Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known)

K203230

Device Name Trade Name: GLOBAL FX

Indications for Use (Describe)

The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
1. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
1. Ununited humeral head fractures;
1. Avascular necrosis of the humeral head.

GLOBAL FX Shoulder Systems Fixation Methods

The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
· POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
· Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
· Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

Type of Use (Select one or both, as applicable)

☑ Remediation Use (Part 61 CFR 331 Subpart D)	☐ On-Site Corrective Use (61 CFR 331 Subpart C)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

☑ Remediation Use (Part 61 CFR 331 Subpart D)

☐ On-Site Corrective Use (61 CFR 331 Subpart C)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K203230

Device Name Trade Name: GLOBAL™ CAP

Indications for Use (Describe) GLOBAL™ CAP

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

GLOBAL™ CAP CTA™

The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

Rotator cuff tear arthropathy.
Difficult clinical management problems where other methods of treatment may not be inadequate.

The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{6}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{7}------------------------------------------------

510(k) Number (if known)

K203230

Device Name Trade Name: Global APG

Indications for Use (Describe)

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
1. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).

Glenoid components are intended for cemented use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known) K203230

Device Name

Trade Name: GLOBAL AP Shoulder System

Indications for Use (Describe) The DePuy GLOBAL AP Shoulder System

The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
1. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its
blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:

1. Ununited humeral head fractures;
1. Avascular necrosis of the humeral head.

GLOBAL AP™ CTA Humeral Heads

The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator
cuff tears.

The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.

GLOBAL APTM Shoulder Systems Fixation Methods.

The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:

POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{9}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{10}------------------------------------------------

510(k) Number (if known) K203230

Device Name

Trade Name: Global StepTech

Indications for Use (Describe)

The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
1. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Glenoid components are intended for cemented use only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{11}------------------------------------------------

510(k) Number (if known) K203230

Device Name Trade Name: Global Shoulder

Indications for Use (Describe)

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Glenoid components are intended for cemented use only.

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{12}------------------------------------------------

510(k) Number (if known) K203230

Device Name Trade Name: DELTA CTA™

Indications for Use (Describe)

The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:

1. Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
1. The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
1. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.

For US use only: All components are intended for cemented use only

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{13}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Contact Person:	Megan Bernier
Email:	mberniel@its.jnj.com
Phone/Fax:	(651) 325-1178 ; FAX (612) 435-2377
Mobile:	(651) 325-1178
Date Prepared:Prepared By:	March 30, 2021Megan Bernier
Trade/Device Name:	Global Shoulder andDelta CTA systems
Regulation Name:	Shoulder JointMetal/PolymerSemi-ConstrainedCemented Prosthesis
Product Codes:	KWS:888.3660KWT:888.3650HSD:888.3690MBF:888.3670PHX:888.3660

{14}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

II. DEVICE

Table 5- 1 Global Shoulder - GLOBAL ADVANTAGE

Trade Name: GLOBAL ADVANTAGE
Device Name:	GlobalTMShoulder-GlobalTM FxHumeral Stem-+GlobalTMAdvantage®Humeral Head	GlobalAdvantageShoulder,GlobalAdvantageHumeral Stem,GlobalAdvantageEccentric Head	Global AdvantageExtended HumeralHead	Global Advantage HumeralStem with Porocoat
Common Name:	Shoulderprosthesis,humeral head	Shoulderprosthesis,humeral head	Prosthesis, Shoulder,Humeral Head	Prosthesis, Shoulder,Humeral Head
ClassificationName:	Prosthesis,Shoulder, Semi-Constrained,Metal/PolymerCemented	Prosthesis,Shoulder,Semi-Constrained,Metal/PolymerCemented	Prosthesis, Shoulder,Hemi-, Humeral,Metallic Uncemented	Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer,Uncemented
Product Code:	KWT	KWS	HSD	MBF
Regulatory Class:	Class II	Class II	Class II	Class II
Regulation Number:	888.3670	888.3660	888.3690	888.3670
510 (k) ReviewPanel:	Orthopedic	Orthopedic	Orthopedic	Orthopedic

Table 5- 2 Global Shoulder - GLOBAL FX

Trade Name: Global FX
Device Name:	Global FX Porous-coatedhumeral STEM	Global FX Porous-coatedhumeral STEM
Common Name:	Shoulder prosthesis, humeralhead	Shoulder prosthesis, humeralhead
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder, Hemi-,Humeral, MetallicUncemented
Product Code:	KWT	MBF
Regulatory Class:	Class II	Class II
Regulation Number:	888.3670	888.3670
510 (k) ReviewPanel:	Orthopedic	Orthopedic

{15}------------------------------------------------

Trade Name: Global CAP
Device Name:	DePuy Global CAP™ HAResurfacing ShoulderHumeral	DePuy Global CAP CTAResurfacing Shoulder
Common Name:	Prosthesis, Shoulder,Humeral Head	Prosthesis, Shoulder,Humeral Head
ClassificationName:	Prosthesis, Shoulder, Hemi-,Humeral, MetallicUncemented	Prosthesis, Shoulder,Hemi-, Humeral, MetallicUncemented
Product Code:	HSD	HSD
Regulatory Class:	Class II	Class II
Regulation Number:	888.3690	888.3690
510 (k) ReviewPanel:	Orthopedic	Orthopedic

Table 5- 3 Global Shoulder - GLOBAL™ CAP

Table 5- 4 Global Shoulder - Global APG

Trade Name: Global APG
Device Name:	DePuy Global Shoulder Glenoid	DePuy Global Shoulder CrosslinkGlenoid DePuy Orthopaedica. Inc.
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented
Product Code:	KWS	KWS
Regulatory Class:	Class II	Class II
Regulation Number:	888.3660	888.3660
510 (k) ReviewPanel:	Orthopedic	Orthopedic

Table 5- 5 Global Shoulder - GLOBAL AP

Trade Name: Global AP
Device Name:	DePuy Global APTMShoulder System	Global AP Porous Coated HumeralSteme	DePuy Global AP CTAHumeral Head
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis	Prosthesis, Shoulder,Humeral Head
Classification Name:	Prosthesis, Shoulder,Semi-Constrained,Metal/PolymerCemented	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder,Hemi-, Humeral,Metallic Uncemented
Product Code:	KWS	KWS	HSD
Regulatory Class:	Class II	Class II	Class II
Regulation Number:	888.3660	888.3660	888.3690
510 (k) ReviewPanel:	Orthopedic	Orthopedic	Orthopedic

{16}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

Trade Name: GLOBAL® STEPTECH®
Device Name:	Global Shoulder StepTech Anchor Peg Glenoid
Common Name:	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Product Code:	KWS
Regulatory Class:	Class II
Regulation Number:	888.3660
510(k) Review Panel:	Orthopedic

Table 5- 6 Global Shoulder – Global StepTech

Table 5- 7 Global Shoulder - Global Shoulder

Trade Name: GLOBAL® SHOULDER
Device Name:	Device Name Global™ TotalShoulder W/DuPont EnhancedUHMWPE	DePuy Global ShoulderCrosslink Glenoid
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Non-Constrained, Metal/polymerCemented	Prosthesis, Shoulder,Semi-Constrained,Metal/PolymerCemented
Product Code:	KWT	KWS
Regulatory Class:	Class II	Class II
Regulation Number:	888.3650	888.3660
510 (k) ReviewPanel:	Orthopedic	Orthopedic

{17}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

DePuy Synthes

Table 5- 8 DELTA CTA™

Trade Name: DELTA CTA
Device Name:	Delta Shoulder	Delta Humeral Cups	Delta Reverse Shoulder SystemHumeral Head	DePuy CTA Reverse Shoulder System
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis	Shoulder Prosthesis	Shoulder Prosthesis
ClassificationName:	Shoulder Prosthesis, ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration
Product Code:	PHX	PHX	PHX	PHX
Regulatory Class:	Class II	Class II	Class II	Class II
RegulationNumber:	888.3660	888.3660	888.3660	888.3660
510 (k) ReviewPanel:	Orthopedic	Orthopedic	Orthopedic	Orthopedic

III. PREDICATE DEVICE(S)

Table 5- 9 Predicate Devices: Global Shoulder - GLOBAL ADVANTAGE

Trade Name: GLOBAL ADVANTAGE®
	K984541	K992065	K000575	K011047
DeviceName:	Global™ Shoulder-Global™ FxHumeral Stem-+Global™Advantage®Humeral Head	GlobalAdvantageShoulder, GlobalAdvantageHumeral Stem,GlobalAdvantageEccentric Head	Global AdvantageExtended HumeralHead	GlobalAdvantageHumeral Stemwith Porocoat
CommonName:	Shoulderprosthesis,humeral head	Shoulderprosthesis,humeral head	Prosthesis,Shoulder, HumeralHead	Prosthesis,Shoulder,Humeral Head
ClassificationName:	Prosthesis,Shoulder, Semi-Constrained,Metal/PolymerCemented	Prosthesis,Shoulder, Semi-Constrained,Metal/PolymerCemented	Prosthesis,Shoulder, Hemi,Humeral, MetallicUncemented	Prosthesis,Shoulder, Semi-Constrained,Metal/Polymer,Uncemented
ProductCode:	KWT	KWS	HSD	MBF
RegulatoryClass:	Class II	Class II	Class II	Class II
RegulationNumber:	888.3670	888.3660	888.3690	888.3670

{18}------------------------------------------------

Trade Name: Global FX
	K984541	K011099
Device Name:	Global FX Porous-coatedhumeral STEM	Global FX Porous-coatedhumeral STEM
Common Name:	Shoulder prosthesis, humeralhead	Shoulder prosthesis, humeralhead
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder, Hemi-,Humeral, MetallicUncemented
Product Code:	KWT	MBF
Regulatory Class:	Class II	Class II
Regulation Number:	888.3670	888.3670

Table 5- 10 Predicate Devices: Global Shoulder - GLOBAL FX

Table 5- 11 Predicate Devices: Global Shoulder - GLOBAL™ CAP

Trade Name: Global CAP
	K033516	K080990
Device Name:	DePuy Global CAP™ HAResurfacing ShoulderHumeral	DePuy Global CAP CTAResurfacing Shoulder
Common Name:	Prosthesis, Shoulder,Humeral Head	Prosthesis, Shoulder,Humeral Head
ClassificationName:	Prosthesis, Shoulder, Hemi-,Humeral, MetallicUncemented	Prosthesis, Shoulder,Hemi-, Humeral, MetallicUncemented
Product Code:	HSD	HSD
Regulatory Class:	Class II	Class II
Regulation Number:	888.3690	888.3690

Table 5- 12 Predicate Devices: Global Shoulder - Global APG

Trade Name: Global APG
	K981487	K052472
Device Name:	DePuy Global Shoulder Glenoid	DePuy Global ShoulderCrosslink Glenoid DePuyOrthopaedica. Inc.
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented
Product Code:	KWS	KWS
Regulatory Class:	Class II	Class II
Regulation Number:	888.3660	888.3660

{19}------------------------------------------------

Table 5- 13 Predicate Devices: Global Shoulder - GLOBAL AP
Trade Name: Global AP
	K060874	K063652	K082715
Device Name:	DePuy Global APTMShoulder System	Global AP Porous Coated HumeralStem	DePuy Global AP CTAHumeral Head
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis	Prosthesis, Shoulder,Humeral Head
Classification Name:	Prosthesis, Shoulder,Semi-Constrained,Metal/PolymerCemented	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented	Prosthesis, Shoulder,Hemi-, Humeral,Metallic Uncemented
Product Code:	KWS	KWS	HSD
Regulatory Class:	Class II	Class II	Class II
Regulation Number:	888.3660	888.3660	888.3690

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ CLODAL AD Clobol Ch E

Table 5- 14 Predicate Devices: Global Shoulder – Global StepTech

Trade Name: GLOBAL® STEPTECH®
	K092122
Device Name:	Global Shoulder StepTech AnchorPeg Glenoid
Common Name:	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented
Product Code:	KWS
Regulatory Class:	Class II
Regulation Number:	888.3660

Table 5- 15 Predicate Devices: Global Shoulder - Global Shoulder
------------------------------------------------------------------	--

Trade Name: GLOBAL® SHOULDER
	K914000; K905786	K052472
Device Name:	Device Name Global™ TotalShoulder W/DuPont EnhancedUHMWPE	DePuy Global ShoulderCrosslink Glenoid
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Non-Constrained, Metal/polymerCemented	Prosthesis, Shoulder,Semi-Constrained,Metal/PolymerCemented
Product Code:	KWT	KWS
Regulatory Class:	Class II	Class II
Regulation Number:	888.3650	888.3660

{20}------------------------------------------------

	Trade Name: DELTA CTA; IFU: W90926 and W90916
	K021478	K050315	K062116	K122442
Device Name:	Delta Shoulder	Delta Humeral Cups	Delta ReverseShoulder SystemHumeral Head	DePuy CTA ReverseShoulder System
Common Name:	Shoulder Prosthesis	Shoulder Prosthesis	Shoulder Prosthesis	Shoulder Prosthesis
ClassificationName:	Shoulder Prosthesis, ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration	Shoulder Prosthesis,ReverseConfiguration
Product Code:	PHX	PHX	PHX	PHX
Regulatory Class:	Class II	Class II	Class II	Class II
RegulationNumber:	888.3660	888.3660	888.3660	888.3660

Table 5- 16 Predicate Devices: DELTA CTATM

IV. DEVICE DESCRIPTION

The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.

{21}------------------------------------------------

Traditional 510(k) Notification

Global Shoulder and Delta CTA MRI

INDICATIONS FOR USE V.

Global Shoulder - GLOBAL ADVANTAGE

The DePuy GLOBAL ADVANTAGE Shoulder Systems

The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its

blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;

Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of

a failed primary component).

The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemishoulder replacement for the treatment of:

Ununited humeral head fractures:
Avascular necrosis of the humeral head.

GLOBAL ADVANTAGE CTA Humeral Heads

The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemishoulder replacement in patients with rotator cuff tears.

The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.

GLOBAL ADVANTAGE Shoulder Systems Fixation Methods

The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:

POROCOAT™ Porous-Coated Components Porocoat porous-coated humeral . stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.

{22}------------------------------------------------

. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components Humeral stem prostheses without porous . coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

Global Shoulder – GLOBAL FX

The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its

blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;

Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of

a failed primary component);

1. Ununited humeral head fractures:
1. Avascular necrosis of the humeral head.

GLOBAL FX Shoulder Systems Fixation Methods

The DePuy GLOBAL FX Shoulder Systems are indicated for the following fixation methods:

. POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components Humeral stem prostheses without porous . coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

{23}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

Global Shoulder – GLOBAL™ CAP

GLOBAL™ CAP

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative ioint disease (i.e. osteoarthritis and avascular necrosis). deformity and/or limited motion. fractures of the humeral head and traumatic arthritis.

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

GLOBAL™ CAP CTA™

The DePuy GLOBAL™ CAP CTA Resurfacing Shoulder is indicated only for hemishoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

Rotator cuff tear arthropathy.
Difficult clinical management problems where other methods of treatment may not be suitable or mav be inadequate.

The DePuy GLOBAL™ CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

{24}------------------------------------------------

Traditional 510(k) Notification Global Shoulder and Delta CTA MRI

Global Shoulder - Global APG

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).

Glenoid components are intended for cemented use only.

{25}------------------------------------------------

Traditional 510(k) Notification

Global Shoulder and Delta CTA MRI

Global Shoulder - GLOBAL AP Shoulder System

The DePuy GLOBAL AP Shoulder System

The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its

blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory:

Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of

a failed primary component).

The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:

Ununited humeral head fractures;
Avascular necrosis of the humeral head.

GLOBAL AP™ CTA Humeral Heads

The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.

The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.

GLOBAL APTM Shoulder Systems Fixation Methods.

The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:

POROCOAT™ Porous-Coated Components Porocoat porous-coated humeral . stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

{26}------------------------------------------------

. Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

Global Shoulder - Global StepTech

The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its

blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.

Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).

Glenoid components are intended for cemented use only.

Global Shoulder – Global Shoulder

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Glenoid components are intended for cemented use only.

{27}------------------------------------------------

Global Shoulder - DELTA CTATM

The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:

Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
The Patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessarv to use the device.

For US use only: All components are intended for cemented use only.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject devices maintain the design characteristics of the predicate devices. Intended use of the subject devices remains the same as the predicate devices. The subject devices are provided with additional labeling language regarding magnetic resonance (MR) compatibility when compared to the predicate devices.

VII. MATERIALS

The subject device materials remain identical to the predicate device materials.

VIII. PERFORMANCE DATA

Non-clinical testing was conducted with the following standards:

• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants • ASTM F2182 Standard Test Method for Measurement of Radio Frequency

Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

Results demonstrated compatibility conditions of the subject devices in the MR environment.

{28}------------------------------------------------

IX. CONCLUSION

Evaluation of subject device intended use and technological characteristics demonstrates substantial equivalence with the predicate devices. Performance data supports the addition of magnetic resonance compatibility information to subject device labeling.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”